AccessGUDID - DEVICE: RAPID RESPONSE EMERGENCY KIT (10850015055598)

GUDID

Device Identifier (DI) Information

Brand Name: RAPID RESPONSE EMERGENCY KIT
Version or Model: H-11044
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ULINE, INC.

Primary DI Number: 10850015055598
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 039612668 *Terms of Use

Device Description: 4.25" X 24" FLEX PADDED SPLINT ARC FIRST AID GUIDE ANSI 2021 NITRILE EXAM GLOVES 2/BAG ANSI TRIANGULAR BDG 1/BAG COLD PACK 4X5 BULK CPR FACE SHIELD W/1-WAY VALVE 3X3" STERILE GAUZE PAD (2 PACK) WINDLASS TOURNIQUET NUSTAT HEMOSTATIC GAUZE PAD 4"X4" HEMA-SEAL 8X10 COMPRESSED TRAUMA DRESSING BULK 5"X9" COMBINE DRESSING BULK TOURNIQUET BULK 1"X18" 1/2" X 5YD ADHESIVE TAPE BULK STERILE BURN DRESSING 4"X4" BZK WIPES, FAO, 5X7, SINGLE WIPE FIRST AID BURN CREAM PKT 0.9G 4.75" BLACK BANDAGE SHEAR 2" X 4YD NS GAUZE ROLL BULK HAND SANITIZER 0.9GM BULK EYEWASH 4 OZ (SCREW TOP) 4" X 4 YD HS GAZUE ROLL BULK STERILE EYE PAD BULK SANIZIDE PLUS WIPES LG BULK ABSORBENT POWDER 2OZ HEAT SEALED BAG SCOOP/SPATULA PLASTIC BULK NON-SURGICAL GOWNS PAPER TOWELS BULK FACE MASK W/SHIELD BIOHAZARD BAG 24X24 BULK ANTIMICROBIAL WIPES "PAWS" BAG PLASTIC 10X12" RECLOSABLE TWIST TIES (GREEN) ALCOHOL PREP PAD, FAO, SOLDIER, STERILE NEOMYCIN ANTIBIOTIC OINTMENT 0.9G BULK BANDAGE PLASTIC 1X3" 5-UP 1X3" FABRIC ADHESIVE BANDAGES 5-UP EMERGENCY BLANKET

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44039	First aid kit, medicated	A convenient collection of equipment, materials and pharmaceuticals intended to be used in an emergency for the rapid, initial treatment of an injury. It is typically used by emergency medical services (EMS), hospitals, institutions, schools, and other public settings. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRR	First Aid Kit With Drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a250d43f-228c-460e-b0ea-62d3f5ac00de
Public Version Date: February 06, 2024
Public Version Number: 1
DI Record Publish Date: January 29, 2024